Testowanie kabozantynibu z atezolizumabem lub bez atezolizumabu u pacjentów z zaawansowanym rakiem brodawkowatym nerki, badanie PAPMET2
Randomizowane badanie fazy II kabozantynibu (NSC nr 761968) z atezolizumabem lub bez (NSC nr 783608) u pacjentów z zaawansowanym rakiem brodawkowatym nerki (PAPMET2)
This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread from where it first started (primary site) to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of tumor cells. Combination therapy with atezolizumab and cabozantinib may shrink the tumor and allow a longer survival time in patients with metastatic renal cell carcinoma.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
PRIMARY OBJECTIVE:
I. To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib (cabozantinib S-malate) with atezolizumab versus cabozantinib alone.
SECONDARY OBJECTIVES:
I. To compare overall survival in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) objective response rate (confirmed and unconfirmed, complete and partial response) in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
III. To evaluate the quantitative and qualitive adverse events observed in each treatment arm.
BANKING OBJECTIVE:
I. To bank biospecimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial.
ARM II: Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 5 years.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Arizona
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Gilbert, Arizona, Stany Zjednoczone, 85234
- Banner MD Anderson Cancer Center
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Phoenix, Arizona, Stany Zjednoczone, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- University of Arkansas for Medical Sciences
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California
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Anaheim, California, Stany Zjednoczone, 92806
- Kaiser Permanente-Anaheim
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Baldwin Park, California, Stany Zjednoczone, 91706
- Kaiser Permanente-Baldwin Park
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Bellflower, California, Stany Zjednoczone, 90706
- Kaiser Permanente-Bellflower
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Duarte, California, Stany Zjednoczone, 91010
- City of Hope Comprehensive Cancer Center
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Dublin, California, Stany Zjednoczone, 94568
- Epic Care-Dublin
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Emeryville, California, Stany Zjednoczone, 94608
- Epic Care Partners in Cancer Care
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Fontana, California, Stany Zjednoczone, 92335
- Kaiser Permanente-Fontana
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Harbor City, California, Stany Zjednoczone, 90710
- Kaiser Permanente South Bay
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Irvine, California, Stany Zjednoczone, 92618
- Kaiser Permanente-Irvine
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Los Angeles, California, Stany Zjednoczone, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Stany Zjednoczone, 90034
- Kaiser Permanente West Los Angeles
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Martinez, California, Stany Zjednoczone, 94553-3156
- Contra Costa Regional Medical Center
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Ontario, California, Stany Zjednoczone, 91761
- Kaiser Permanente-Ontario
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Panorama City, California, Stany Zjednoczone, 91402
- Kaiser Permanente - Panorama City
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Riverside, California, Stany Zjednoczone, 92505
- Kaiser Permanente-Riverside
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Sacramento, California, Stany Zjednoczone, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Stany Zjednoczone, 92120
- Kaiser Permanente-San Diego Zion
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San Marcos, California, Stany Zjednoczone, 92078
- Kaiser Permanente-San Marcos
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Walnut Creek, California, Stany Zjednoczone, 94597
- Epic Care Cyberknife Center
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Woodland Hills, California, Stany Zjednoczone, 91367
- Kaiser Permanente-Woodland Hills
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District of Columbia
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Washington D.C., District of Columbia, Stany Zjednoczone, 20007
- MedStar Georgetown University Hospital
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Idaho
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Boise, Idaho, Stany Zjednoczone, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Stany Zjednoczone, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Stany Zjednoczone, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Stany Zjednoczone, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Stany Zjednoczone, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Stany Zjednoczone, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Stany Zjednoczone, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Stany Zjednoczone, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Stany Zjednoczone, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Stany Zjednoczone, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Stany Zjednoczone, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Stany Zjednoczone, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University
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Danville, Illinois, Stany Zjednoczone, 61832
- Carle at The Riverfront
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DeKalb, Illinois, Stany Zjednoczone, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Stany Zjednoczone, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Stany Zjednoczone, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Stany Zjednoczone, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Stany Zjednoczone, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Stany Zjednoczone, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Stany Zjednoczone, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Stany Zjednoczone, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Stany Zjednoczone, 60026
- Northwestern Medicine Glenview Outpatient Center
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Grayslake, Illinois, Stany Zjednoczone, 60030
- Northwestern Medicine Grayslake Outpatient Center
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Kewanee, Illinois, Stany Zjednoczone, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Stany Zjednoczone, 60045
- Northwestern Medicine Lake Forest Hospital
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Macomb, Illinois, Stany Zjednoczone, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Stany Zjednoczone, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Stany Zjednoczone, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Stany Zjednoczone, 62269
- Cancer Care Center of O'Fallon
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Orland Park, Illinois, Stany Zjednoczone, 60462
- Northwestern Medicine Orland Park
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Stany Zjednoczone, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Stany Zjednoczone, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Stany Zjednoczone, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Stany Zjednoczone, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Stany Zjednoczone, 61114
- UW Health Carbone Cancer Center Rockford
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Shiloh, Illinois, Stany Zjednoczone, 62269
- Memorial Hospital East
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Springfield, Illinois, Stany Zjednoczone, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Stany Zjednoczone, 62702
- Springfield Clinic
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Springfield, Illinois, Stany Zjednoczone, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Stany Zjednoczone, 61801
- Carle Cancer Center
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Warrenville, Illinois, Stany Zjednoczone, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Stany Zjednoczone, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Stany Zjednoczone, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Stany Zjednoczone, 50010
- McFarland Clinic - Ames
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Ankeny, Iowa, Stany Zjednoczone, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Boone, Iowa, Stany Zjednoczone, 50036
- McFarland Clinic - Boone
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Clive, Iowa, Stany Zjednoczone, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stany Zjednoczone, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Stany Zjednoczone, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Stany Zjednoczone, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Stany Zjednoczone, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Stany Zjednoczone, 50158
- McFarland Clinic - Marshalltown
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Waukee, Iowa, Stany Zjednoczone, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Kansas
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Topeka, Kansas, Stany Zjednoczone, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
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Louisiana
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Metairie, Louisiana, Stany Zjednoczone, 70006
- East Jefferson General Hospital
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Metairie, Louisiana, Stany Zjednoczone, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
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Metairie, Louisiana, Stany Zjednoczone, 70002
- Mary Bird Perkins Cancer Center - Metairie
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New Orleans, Louisiana, Stany Zjednoczone, 70112
- University Medical Center New Orleans
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New Orleans, Louisiana, Stany Zjednoczone, 70115
- Touro Infirmary
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Stany Zjednoczone, 49017
- Bronson Battle Creek
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Brighton, Michigan, Stany Zjednoczone, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Stany Zjednoczone, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Stany Zjednoczone, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Canton, Michigan, Stany Zjednoczone, 48188
- Trinity Health Medical Center - Canton
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Caro, Michigan, Stany Zjednoczone, 48723
- Caro Cancer Center
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Chelsea, Michigan, Stany Zjednoczone, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea, Michigan, Stany Zjednoczone, 48118
- Chelsea Hospital
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Detroit, Michigan, Stany Zjednoczone, 48201
- Wayne State University/Karmanos Cancer Institute
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Farmington Hills, Michigan, Stany Zjednoczone, 48334
- Weisberg Cancer Treatment Center
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Flint, Michigan, Stany Zjednoczone, 48503
- Hurley Medical Center
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Flint, Michigan, Stany Zjednoczone, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Stany Zjednoczone, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Stany Zjednoczone, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Stany Zjednoczone, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Stany Zjednoczone, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Stany Zjednoczone, 49009
- Beacon Kalamazoo Cancer Center
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Lansing, Michigan, Stany Zjednoczone, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Stany Zjednoczone, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Marlette, Michigan, Stany Zjednoczone, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
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Muskegon, Michigan, Stany Zjednoczone, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Stany Zjednoczone, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Stany Zjednoczone, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Stany Zjednoczone, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Saginaw, Michigan, Stany Zjednoczone, 48604
- Oncology Hematology Associates of Saginaw Valley PC
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Saginaw, Michigan, Stany Zjednoczone, 48601
- MyMichigan Medical Center Saginaw
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Saint Joseph, Michigan, Stany Zjednoczone, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Tawas City, Michigan, Stany Zjednoczone, 48764
- MyMichigan Medical Center Tawas
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Traverse City, Michigan, Stany Zjednoczone, 49684
- Munson Medical Center
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West Branch, Michigan, Stany Zjednoczone, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
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Wyoming, Michigan, Stany Zjednoczone, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Stany Zjednoczone, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Ypsilanti, Michigan, Stany Zjednoczone, 48106
- Huron Gastroenterology PC
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Minnesota
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Coon Rapids, Minnesota, Stany Zjednoczone, 55433
- Mercy Hospital
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Edina, Minnesota, Stany Zjednoczone, 55435
- Fairview Southdale Hospital
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Maplewood, Minnesota, Stany Zjednoczone, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Stany Zjednoczone, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Stany Zjednoczone, 55101
- Regions Hospital
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Saint Paul, Minnesota, Stany Zjednoczone, 55102
- United Hospital
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Mississippi
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Jackson, Mississippi, Stany Zjednoczone, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Stany Zjednoczone, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Stany Zjednoczone, 63141
- Siteman Cancer Center at West County Hospital
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Farmington, Missouri, Stany Zjednoczone, 63640
- Parkland Health Center - Farmington
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Sainte Genevieve, Missouri, Stany Zjednoczone, 63670
- Sainte Genevieve County Memorial Hospital
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St Louis, Missouri, Stany Zjednoczone, 63110
- Washington University School of Medicine
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St Louis, Missouri, Stany Zjednoczone, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Stany Zjednoczone, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Stany Zjednoczone, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Stany Zjednoczone, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Stany Zjednoczone, 63128
- Mercy Hospital South
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Sullivan, Missouri, Stany Zjednoczone, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Anaconda, Montana, Stany Zjednoczone, 59711
- Community Hospital of Anaconda
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Billings, Montana, Stany Zjednoczone, 59101
- Billings Clinic Cancer Center
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Billings, Montana, Stany Zjednoczone, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, Stany Zjednoczone, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Stany Zjednoczone, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Stany Zjednoczone, 59901
- Logan Health Medical Center
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Missoula, Montana, Stany Zjednoczone, 59804
- Community Medical Center
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Stany Zjednoczone, 89183
- OptumCare Cancer Care at Fort Apache
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New Jersey
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Hackensack, New Jersey, Stany Zjednoczone, 07601
- Hackensack University Medical Center
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North Carolina
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Cary, North Carolina, Stany Zjednoczone, 27518
- Duke Cancer Center Cary
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Clinton, North Carolina, Stany Zjednoczone, 28328
- Southeastern Medical Oncology Center-Clinton
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke University Medical Center
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Goldsboro, North Carolina, Stany Zjednoczone, 27534
- Southeastern Medical Oncology Center-Goldsboro
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Jacksonville, North Carolina, Stany Zjednoczone, 28546
- Southeastern Medical Oncology Center-Jacksonville
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Pinehurst, North Carolina, Stany Zjednoczone, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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Raleigh, North Carolina, Stany Zjednoczone, 27609
- Duke Cancer Center Raleigh
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Ohio
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Avon, Ohio, Stany Zjednoczone, 44011
- UH Seidman Cancer Center at UH Avon Health Center
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Beachwood, Ohio, Stany Zjednoczone, 44122
- UHHS-Chagrin Highlands Medical Center
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Centerville, Ohio, Stany Zjednoczone, 45459
- Miami Valley Hospital South
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Cleveland, Ohio, Stany Zjednoczone, 44106
- Case Western Reserve University
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Dayton, Ohio, Stany Zjednoczone, 45409
- Miami Valley Hospital
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Dayton, Ohio, Stany Zjednoczone, 45415
- Miami Valley Hospital North
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Dayton, Ohio, Stany Zjednoczone, 45415
- Dayton Physician LLC - Englewood
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Dayton, Ohio, Stany Zjednoczone, 45409
- Premier Blood and Cancer Center
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Franklin, Ohio, Stany Zjednoczone, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Stany Zjednoczone, 45331
- Miami Valley Cancer Care and Infusion
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Kettering, Ohio, Stany Zjednoczone, 45429
- Kettering Medical Center
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Troy, Ohio, Stany Zjednoczone, 45373
- Upper Valley Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, Stany Zjednoczone, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Oregon
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Newberg, Oregon, Stany Zjednoczone, 97132
- Providence Newberg Medical Center
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Ontario, Oregon, Stany Zjednoczone, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Oregon City, Oregon, Stany Zjednoczone, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Stany Zjednoczone, 97239
- Oregon Health and Science University
-
Portland, Oregon, Stany Zjednoczone, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97225
- Providence Saint Vincent Medical Center
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Texas
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Dallas, Texas, Stany Zjednoczone, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, Stany Zjednoczone, 75237
- UT Southwestern Simmons Cancer Center - RedBird
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Fort Worth, Texas, Stany Zjednoczone, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
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Richardson, Texas, Stany Zjednoczone, 75080
- UT Southwestern Clinical Center at Richardson/Plano
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San Antonio, Texas, Stany Zjednoczone, 78229
- University of Texas Health Science Center at San Antonio
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Utah
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Farmington, Utah, Stany Zjednoczone, 84025
- Farmington Health Center
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Salt Lake City, Utah, Stany Zjednoczone, 84112
- Huntsman Cancer Institute/University of Utah
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Virginia
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Richmond, Virginia, Stany Zjednoczone, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Stany Zjednoczone, 23298
- VCU Massey Comprehensive Cancer Center
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West Virginia
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Charleston, West Virginia, Stany Zjednoczone, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
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Wisconsin
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Eau Claire, Wisconsin, Stany Zjednoczone, 54701
- Marshfield Medical Center-EC Cancer Center
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Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Medical Center-Marshfield
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Minocqua, Wisconsin, Stany Zjednoczone, 54548
- Marshfield Medical Center - Minocqua
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Rice Lake, Wisconsin, Stany Zjednoczone, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, Stany Zjednoczone, 54482
- Marshfield Medical Center-River Region at Stevens Point
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Weston, Wisconsin, Stany Zjednoczone, 54476
- Marshfield Medical Center - Weston
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
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Participants must have a histologically confirmed diagnosis of metastatic papillary renal cell carcinoma (PRCC), either type 1 or type 2. (NOTE: A designation of type 1 or type 2 should be made by the local pathologist if possible but is not required). Mixed histologies which contain type 1 or type 2 along with any other RCC histology/histologies will be allowed provided that they contain a papillary component
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Participants must have measurable disease per RECIST 1.1 criteria. All measurable lesions must be assessed by CT or MRI within 28 days prior to registration. All non-measurable lesions must be assessed by CT or MRI, or nuclear medicine bone scan within 42 days prior to registration. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. If there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan must be performed at baseline (within 42 days prior to registration)
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Participants with new or progressive brain metastases (active brain metastases) must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling
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Participants with measurable disease, per RECIST version (v)1.1, must be present outside the CNS
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Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage
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Participants must not have undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment
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Participants must not have ongoing requirements for corticosteroids as therapy for CNS disease
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Participants, if needed, must receive a stable dose of anti-convulsant therapy
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Participants must not have cavitating pulmonary lesions
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Participants must not have uncontrolled pleural effusions, pericardial effusions, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g., PleurX [registered trademark]) are allowed
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Participants must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration
-
Participants must not have evidence of tumor invading or encasing any major blood vessels
-
Participants must not have had major surgery within 28 days prior to registration, and participants must have recovered from any adverse effects of surgery
-
Participants must not have had prior treatment with cabozantinib for any reason
-
Participants must not have had prior treatment or adjuvant therapy with PD-1/PD-L1 checkpoint inhibitors for any reason within the past 6 months
-
Participants must not have received more than one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib). If a participant develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC. If a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC
-
Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipranavir/RIT, or voriconazole,); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers
-
Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers
-
Participants must complete all prior radiation therapy at least 14 days prior to registration. Participants must have recovered to =< grade 1 from all associated toxicities at the time of registration unless the toxicity is determined to be not clinically significant by the registering investigator
-
Participants must not be receiving or planning to receive any other investigational agents at time of registration
-
Participants must not have been diagnosed with a clinically significant autoimmune disease, exceptions such as diabetes, eczema, and vitiligo are allowed. Other non-clinically significant autoimmune diseases are allowed if approved by the registering investigator
-
Participants must not be on steroid doses > 10 mg prednisone equivalent. Replacement steroid doses for adrenal insufficiency will be allowed. Also, short duration steroid therapy to prevent allergic reactions are acceptable (e.g. prior to CT imaging)
-
Participants must be >= 18 years of age
-
Participants must have a complete physical examination and medical history within 28 days prior to registration
-
Participants must have a Zubrod performance status of 0-2
-
White blood count (WBC) >= 2 x 10^3/uL (within 28 days prior to registration)
-
Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (within 28 days prior to registration)
-
Platelet count >= 100 x 10^3/uL (within 28 days prior to registration)
-
Lymphocyte count >= 0.5 x 10^3/uL (within 28 days prior to registration)
-
Hemoglobin (>= 9 g/dL) (within 28 days prior to registration). Participants may be transfused to meet this criterion
-
Total serum bilirubin =< 1.5 x the institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration). Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN
-
Aspartate aminotransferase (AST) must be =< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT) must be =< 5 x the institutional ULN (within 28 days prior to registration)
-
Alanine aminotransferase (ALT), must be =< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGPT) must be =< 5 x the institutional ULN (within 28 days prior to registration)
-
Participants must have serum creatinine =< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) > 30 mL/min and obtained within 28 days prior to registration
-
Participants must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration
-
Participants must not have known history of congenital long QT syndrome and must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 90 days prior to registration
-
Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days of registration, unless clinically stable with ongoing medical management
-
Participants must have urine protein < 3+ within 28 days prior to registration. If urine protein is 3+ or greater, then urine protein by 24-hour collection must show less than 3 grams of protein
-
Participants must have documented blood pressure of systolic blood pressure (SBP) < 150 mm Hg or diastolic blood pressure (DBP) < 100 mm Hg within 14 days prior to registration
-
Participants with known human immunodeficiency virus (HIV) must be on effective anti-retroviral therapy at registration and have undetectable viral load within 6 months of registration
-
Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy within 6 months prior to registration, if indicated
-
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load within 6 months prior to registration
-
Participants must be able to take oral medications (i.e., swallow pills whole). Participants must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease. Participants with intractable nausea or vomiting are not eligible
-
Participants must not have had any clinically-significant GI bleeding within 3 months prior to registration and participants must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula (e.g. Crohn's disease)
-
Participants must not have had hemoptysis of >= (2.5 mL) of red blood, and do not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior registration
-
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
-
Participants must not be pregnant or nursing, due to VEGF therapy being toxic to embryogenesis. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
-
Participants must not be on warfarin, at therapeutic doses. Low dose aspirin for cardio-protection (per local applicable guidelines) and low molecular weight heparin (LMWH) are allowed
-
Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
-
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- NOTE: For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
-
As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Aktywny komparator: Arm I (cabozantinib S-malate)
Patients receive cabozantinib S-malate PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial. |
Undergo MRI
Inne nazwy:
Given PO
Inne nazwy:
Undergo collection of blood and urine samples
Inne nazwy:
Undergo CT scans
Inne nazwy:
Undergo bone scans
Inne nazwy:
|
|
Eksperymentalny: Arm II (cabozantinib S-malate, atezolizumab)
Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial. |
Undergo MRI
Inne nazwy:
Given PO
Inne nazwy:
Given IV
Inne nazwy:
Undergo collection of blood and urine samples
Inne nazwy:
Undergo CT scans
Inne nazwy:
Undergo bone scans
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Progression free survival
Ramy czasowe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
|
A proportional hazards model will be used to evaluate the experimental arm compared to the control arm, adjusted for the stratification factors as covariates in the model. A one-sided p-value =< 0.05 will indicate statistical significance. Participants last known to be alive and progression free are censored at date of last contact. |
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall survival
Ramy czasowe: From date of registration to date of death due to any cause, assessed up to 5 years
|
Will be estimated by the Kaplan-Meier method, and a stratified log-rank test will be used to compare the treatment arms. Participants last known to be alive are censored at date of last contact. |
From date of registration to date of death due to any cause, assessed up to 5 years
|
|
Objective response rate
Ramy czasowe: Up to 5 years
|
Will be estimated to within +/- 11% (95% confidence interval). |
Up to 5 years
|
|
Incidence of adverse events
Ramy czasowe: Day 1 of each cycle
|
Will be estimated to within +/- 11% (95% confidence interval). Will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for toxicity and serious adverse event reporting. |
Day 1 of each cycle
|
Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Benjamin L Maughan, SWOG Cancer Research Network
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Nowotwory układu moczowo-płciowego
- Nowotwory według lokalizacji
- Nowotwory
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby nerek
- Choroby Urologiczne
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Nowotwory według typu histologicznego
- Nowotwory gruczołowe i nabłonkowe
- Rak gruczołowy
- Nowotwory urologiczne
- Rak
- Nowotwory nerek
- Rak, Komórka Nerki
- Techniki śledcze
- Techniki laboratoryjne kliniczne
- Techniki i procedury diagnostyczne
- Diagnoza
- Techniki chemii, analityczne
- Analiza widma
- Prowadzenie okazów
- Spektroskopia rezonansu magnetycznego
- Atezolizumab
- Cabozantinib
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- NCI-2022-04668
- U10CA180888 (Grant/umowa NIH USA)
- NCI-2022-04668 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
- S2200 (Inny identyfikator: CTEP)
- S2200 (Inny identyfikator: SWOG)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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